Identity
- Trade Name
- Thermode 30X30 (TSA 2) FDA UDI
- Generic Name
- Thermotester, diagnostic FDA UDI
- Device Name
- standard thermal probe, which is capable of heating and cooling the skin. Used on large body sites. FDA UDI
- Model / Reference
- TSA 2 30X30 FDA UDI
- Description
- standard thermal probe, which is capable of heating and cooling the skin. Used on large body sites. FDA UDI
Identifiers
- Catalog Number
- AS 00176 FDA UDI
- Primary DI / UDI-DI
- 07290103039912 FDA UDI
- FDA Product Code
- LQW FDA UDI
- GMDN Term
- Thermotester, diagnostic FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 882.1200 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Thermotester, diagnostic
Thermode 30X30 (TSA 2) by Medoc Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermotester, diagnostic.
- NEURO TOUCH — YOSTRA LABS PRIVATE LIMITED · Class I
- Thermode 30x30mm (Q-Sense) — Medoc Corp. · Class I
- Q-Sense Response Unit — Medoc Corp. · Class I
- Thermode 6mm diameter — Medoc Corp. · Class I
- Contact Heat Evoked Potential Stimulator — Medoc Corp. · Class I
- Thermode fMRI 16X16mm - including fMRI filter — Medoc Corp. · Class I
- Thermode CHEPS fMRI — Medoc Corp. · Class I
- Thermode 16X16 (TSA 2) — Medoc Corp. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Medoc Corp.
Sources (1)
- FDA UDI bcf4b595-b015-4794-a0e1-4ae5bdda7b40 34 fields · synced Jun 8, 2026